Comparison of Three Commercial Batches of the Japanese Encephalitis Vaccine IC51
Phase 3
Completed
- Conditions
- Japanese Encephalitis
- Registration Number
- NCT00595465
- Lead Sponsor
- Valneva Austria GmbH
- Brief Summary
The objective is to demonstrate equivalence of three commercial IC51 batches in terms of geometric mean titers for anti-JEV neutralizing antibody
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 389
Inclusion Criteria
- Male and female healthy adults aged at least 18 years, with written informed consent and either no childbearing potential or negative pregnancy test
Main
Exclusion Criteria
- History of immunodeficiency or immunosuppressive therapy,
- Known Human Immunodeficiency Virus (HIV); OR
- Drug addiction including alcohol dependence
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Geometric Mean Titer (GMT) for Anti-JEV Neutralizing Antibody Day 56
- Secondary Outcome Measures
Name Time Method Seroconversion Rate Day 56 Safety and Adverse Events Day 56
Trial Locations
- Locations (4)
Medizinische Universität Wien, Universitätsklinik für Klinische Pharmakologie
🇦🇹Vienna, Austria
Berliner Zentrum Reise- und Tropenmedizin
🇩🇪Berlin, Germany
Klinikum der Universität München, Abteilung für Infektions- und Tropenmedizin
🇩🇪Munich, Germany
Klinik und Poliklinik für Innere Medizin der Universität Rostock
🇩🇪Rostock, Germany
Medizinische Universität Wien, Universitätsklinik für Klinische Pharmakologie🇦🇹Vienna, Austria